Modular catheter

ABSTRACT

The present disclosure provides a catheter including a plurality of a segments, each segment having a stiffener extending along its length. The plurality of segments are interconnected with connectors such that each of the segments can bend in multiple planes via rotation of the connectors.

RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S.Provisional patent Application Ser. No. 62/970,534, filed Feb. 5, 2020,the entire teachings of which are incorporated herein by reference.

FIELD

The present technology is generally related to catheters for delivery ofa prosthesis.

BACKGROUND

Diseased or otherwise deficient heart valves can be repaired or replacedwith an implanted prosthetic heart valve. Conventionally, heart valvereplacement surgery is an open-heart procedure conducted under generalanesthesia, during which the heart is stopped and blood flow iscontrolled by a heart-lung bypass machine. Traditional open surgeryinflicts significant patient trauma and discomfort, and exposes thepatient to a number of potential risks, such as infection, stroke, renalfailure, and adverse effects associated with the use of the heart-lungbypass machine, for example.

Due to the drawbacks of open-heart surgical procedures, there has beenan increased interest in minimally invasive and percutaneous replacementof cardiac valves. With percutaneous transcatheter (or transluminal)techniques, a valve prosthesis is compacted for delivery in a catheterand then advanced, for example, through an opening in the femoral arteryand through the descending aorta to the heart, where the prosthesis isthen deployed in the annulus of the valve to be restored (e.g., theaortic valve annulus). Although transcatheter techniques have attainedwidespread acceptance with respect to the delivery of conventionalstents to restore vessel patency, only mixed results have been realizedwith percutaneous delivery of the more complex prosthetic heart valve.

A delivery catheter must often navigate through tortuous anatomy as itis tracked through the vasculature to the treatment site within theheart. The catheter may be navigated through various anatomical turns asit travels within the vasculature, including the sharp bend of theaortic arch.

The present disclosure addresses problems and limitations associatedwith the related art.

SUMMARY

The techniques of this disclosure generally relate to a catheter for usein delivering a prosthesis via percutaneous transcatheter (ortransluminal) techniques. It is desirable that the clinician have theability to accurately steer or deflect the catheter as it is guided andadvanced to the treatment site. Embodiments of the disclosure achievedeflection of a delivery catheter as it navigates the anatomy of thevasculature while advancing to a desired treatment site.

In one aspect, the present disclosure provides a catheter including aplurality of a segments, each segment having a stiffener extending alongits length. The plurality of segments are interconnected with connectorssuch that each of the segments can bend in multiple planes via rotationof the connectors.

In another aspect, the disclosure provides a catheter including a firsttubular segment having a distal end and a proximal end; the firsttubular segment further having a body and a set of spine wireslongitudinally arranged with respect to the body. The catheter furtherincludes a second tubular segment having a distal end and a proximalend; the second tubular segment further having a body and a set of spinewires longitudinally arranged with respect to the body. The catheteralso includes a first connector having a first portion connected to thedistal end of the first tubular segment and a second portion connectedto the proximal end of the second tubular segment; wherein the firstportion and the second portion are engaged so that the first and secondportions can rotate with respect to each other.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a conceptual diagram of a catheter having a plurality oftubular segments interconnected by connectors.

FIG. 2 is an exploded view of one connector of FIG. 1 having a firstportion and a second portion.

FIG. 3 is a cross-sectional view of the connector of FIG. 2.

FIG. 4 is a perspective view of the first portion of the connector ofFIGS. 1-3.

FIG. 5 is a perspective view of the second portion of the connector ofFIGS. 1-3.

FIG. 6 is a partial, exploded side view of an alternate catheter.

FIG. 7 is a partial, exploded side view of an alternate catheter.

DETAILED DESCRIPTION

FIGS. 1-5 collectively illustrate a catheter 10 including a plurality oftubular segments 12, 14, 16 interconnected by connectors or torquerelief nodes 20. The catheter 10 can be of the type for delivering aprosthesis (not shown) via percutaneous transcatheter (or transluminal)techniques. In such embodiments, at a proximal end 22 a, the catheter 10can include a handle assembly 24. At a distal end 22 b, the catheter 10can include a capsule 26 for compressively containing the prosthesispositioned therein. During such transcatheter techniques, it is typicalfor the catheter 10 to navigate through a series of bend in differentplanes and to deploy and recapture a prosthesis often requires acatheter that is sufficiently stiff with respect to tension andcompression while maintaining a low bending stiffness, which is uniformaround its circumference. Embodiments of the disclosure provide therequired stiffness in tension and compression while also providingbending of the catheter in multiple planes. This bending functionresults in increased ability for the catheter to track through tortuousanatomies with bends in multiple planes and a reduced track force (i.e.reduced trauma to the patient).

In one example, the catheter 10 includes a first tubular segment 12having a proximal end 30 and a distal end 32. The first tubular segment12 further has a body 34 and a set of stiffeners 36 (e.g., spine wires)longitudinally arranged with respect to the body 34. Only one stiffener36 is visible in FIG. 1, however, additional stiffeners can bepositioned around the body 34, as desired. The catheter 10 also includesa second tubular segment 14 having a proximal end 40 and a distal end42. The second tubular segment 14 further has a body 44 and a set ofspine wires 46 longitudinally arranged with respect to the body 44 (onlyone spine wire 46 is visible as with segment 12). In the illustratedexample, the catheter 10 optionally further includes a third tubularsegment 16 having a proximal end 50 and a distal end 52. The thirdtubular segment 16 further has a body 54 and a set of spine wires 56longitudinally arranged with respect to the body 54 (only one spine wire56 is visible as with segment 12). All segments 12, 14, 16 canoptionally be identically configured or can vary in configuration. Insome embodiments, the catheter 10 includes additional tubular segments(e.g., between 2-10 segments), as desired, and the present disclosure isnot intended to be limited to a particular number of tubular segments.

As previously indicated, one or more of the tubular segments 12, 14, 16includes two spine wires 36, 46, 56 extending along a length of therespective tubular segment 12, 14, 16. In one example, each spine wire36, 46, 56 extends and entire length of the respective tubular segment12, 14, 16. The spine wires 36, 46, 56 are coaxial with a center axis ofthe respective tubular segment 12, 14, 16 and can be embedded within therespective body 34, 44, 54 of the respective tubular segment 12, 14, 16or otherwise attached to the respective body 34, 44, 54. The spine wires36, 46, 56 have a stiffness greater than a stiffness of the body 34, 44,54 to support the body to resist compression, while allowing the body tobend. In one example, the spine wires 36, 46, 56 of a particular tubularsegment 12, 14, 16 are positioned about 180 degrees (+/−5 degrees) abouta circumference of the body 34, 44, 54.

To provide bending of the catheter 10 in multiple planes, two tubularsegments 12, 14, 16 are interconnected with one connector 20interconnecting two respective tubular segments. In the example of FIG.1, the first and second tubular segments 12, 14 are interconnected withone connector 20 and the second and third tubular segments 14, 16 areinterconnected with a second connector 20. As indicated with likereference numerals, it is to be understood that each connector 20provided in the catheter 10 can be identically configured. In someembodiments, the connectors 20 provided can vary with respect to eachother in ways described herein, for example. Each connector 20 includesa first portion 60 and a second portion 62. In on example, the firstportion 60 is connected to the distal end 32 of the first tubularsegment 12 and the second portion 62 is connected to the proximal end 40of the second tubular segment 14. The first portion 60 and the secondportion 62 are engaged so that the first and second portions 60, 62 canrotate about their joint central axis A with respect to each other. Inone example, the first and second portions 60, 62 can rotated 360degrees with respect to each other. In this way, the tubular segments12, 14 of the catheter 10 can rotate relative to each other to navigatetortuous anatomy. It will be understood that the distal/proximal orderof the first and second portions 60, 62 can be reversed as shown inFIGS. 6-7, for example.

One example of suitable connector 20 is shown in greater detail in FIGS.2-5. The first portion 60 includes a first end 70 a having a pluralityof collet segments 74 (two of which are referenced for ease ofillustration). The first portion 60 is shown as having four colletsegments 74, however, more or fewer collet segments are envisioned. Thecollect segments 74 are connected to a mid portion 76. A second end 70 bof the first portion 60 is configured to support and receive one end ofone tubular segment and can optionally have a beveled surface. The midportion 76 can have a larger outer diameter as compared to an outerdiameter of the second end 70 b for the end of the respective tubularsegment to abut against. In one example, the first portion 60 furtherincludes a central aperture 78 extending from the first end 70 a to thesecond end 70 b.

The second portion 62 includes a first end 80 a having a receivingaperture 82 in which the collect segments 74 can be inserted androtatingly retained therein via a ridge 84. In one example, the colletsegments each include a ramped surface 75. Each of the collect segments74 can be compressed toward axis A to slide past ridge 84. Once inreceiving aperture 82, the collect segments 74 snap back away from axisA (see, in particular, FIG. 3). In one example, the first end 80 a ofthe second portion 62 abuts against the mid portion 76 when the firstand second portions 60, 62 are engaged. A second end 80 b of the secondportion 62 is configured to support and receive one end of one tubularsegment and can optionally have a beveled surface. In one example, thesecond portion 62 includes a central aperture 88 extending from thefirst end 80 a to the second end 80 b and in communication with thereceiving aperture 82. In one example, the central aperture 88 has adiameter equal that the central aperture 78. The connector 20 isprovided merely as one example and other connectors suitable forconnecting two tubular segments and allowing rotation of the tubularsegments about each other are also considered within the scope of thepresent disclosure.

Referring now in addition to FIG. 6, which illustrates a portion of analternative catheter 110 that includes a first multi-filar coil 190secured to the first tubular segment 12 adjacent to and connected to thesecond portion 62 of the connector 20 and a second multi-filar coil 190secured to the second tubular segment 14 adjacent to and connected tothe first portion 60 of the connector 20. The multi-filar coils 190create a section of increased flexibility to minimize the stressconcentrated at these locations of the catheter 110. As at leastpartially indicated with like reference numerals, the catheter 110 ofFIG. 6 is otherwise identical to and operates similar to catheter 10disclosed above unless explicitly stated.

Similarly, FIG. 7 illustrates a portion of an alternative catheter 210that includes a first jacket 290 a secured to the first tubular segment12 adjacent to the first portion of the connector 20 and a second jacket290 b secured to the second tubular segment 14 adjacent to the firstportion 60 of the connector 20. Each jacket 290 a, 290 b creates asection of increased stiffness/durometer to minimize the stressconcentrated at the location of the respective jacket. In one example,one or more the jackets 290 a, 290 b has a variable stiffness/durometer.For example, the stiffness of each jacket 290 a, 290 b may increase inthe direction of the connector 20. As at least partially indicated withlike reference numerals, the catheter 210 of FIG. 7 is otherwiseidentical to and operates similar to catheter 10 unless explicitlystated.

In one example, a catheter was tested using a compound bend box havingthree 180 degree bends in different planes. A catheter having two spinewires but not including any connectors disclosed herein got stuck afterthe first bend due to the spine wires limiting the catheter to one planeof bending. In a second test, a catheter including a connector hereinallowed the tubular segments of the catheter rotate in different planes,which enabled the catheter to go through the second bend before gettingstuck in the compound bend box. The tested catheter of the disclosuretraveled approximately 130 mm further through the compound bend box.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

What is claimed is:
 1. A catheter comprising: a first tubular segment having a distal end and a proximal end; the first tubular segment further having a body and a set of spine wires longitudinally arranged with respect to the body; a second tubular segment having a distal end and a proximal end; the second tubular segment further having a body and a set of spine wires longitudinally arranged with respect to the body; and a first connector having a first portion connected to the distal end of the first tubular segment and a second portion connected to the proximal end of the second tubular segment; wherein the first portion and the second portion are engaged so that the first and second portions can rotate with respect to each other.
 2. The catheter of claim 1, further comprising a capsule connected to the distal end of the second tubular segment, the capsule configured to receive a prosthesis.
 3. The catheter of claim 1, wherein the spine wires of the first tubular segment are positioned about 180 degrees from each other.
 4. The catheter of claim 1, wherein the first portion and the second portion can rotate 360 degrees with respect to each other.
 5. The catheter of claim 1, wherein the spine wires of the first tubular segment have a stiffness greater than a stiffness of the body of the first tubular segment.
 6. The catheter of claim 1, wherein the distal end of the first tubular segment includes a multi-filar coil.
 7. The catheter of claim 1, wherein the distal end of the first tubular segment includes a jacket.
 8. The catheter of claim 7, wherein the jacket has a varying durometer.
 9. The catheter of claim 8, wherein the durometer is greatest adjacent the first portion of the first connector.
 10. The catheter of claim 1, wherein the proximal end of the second tubular segment includes a multi-filar coil.
 11. The catheter of claim 1, wherein the proximal end of the second tubular segment includes a jacket.
 12. The catheter of claim 11, wherein the jacket has a varying durometer.
 13. The catheter of claim 12, wherein the durometer is greatest adjacent the second portion of the first connector.
 14. The catheter of claim 1, wherein the first tubular segment is overmolded to the first portion of the first connector.
 15. The catheter of claim 1, wherein one of the first and second portions of the first connector includes a plurality of collet segments.
 16. The catheter of claim 15, wherein the first portion includes a receiving aperture and the second portion includes the plurality of collet segments; wherein the collet segments are rotatingly maintained within the receiving aperture.
 17. The catheter of claim 15, wherein the second portion includes a receiving aperture and the first portion includes the plurality of collet segments; wherein the collet segments are rotatingly maintained within the receiving aperture.
 18. The catheter of claim 1, wherein the first and second portions are connected via a snap-fit.
 19. The catheter of claim 1, further comprising a third tubular segment having a distal end and a proximal end; the third tubular segment further having a body and a set of spine wires longitudinally arranged with respect to the body; and a second connector having a first portion connected to the distal end of the second tubular segment and a second portion connected to the proximal end of the third tubular segment; wherein the first portion of the second connector and the second portion of the second connector are engaged to be rotatable with respect to each other.
 20. A catheter including a plurality of a segments, each segment having a stiffener extending along its length, the plurality of segments interconnected with connectors; wherein each of the segments can bend in multiple planes via rotation of the connectors. 